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Self-Compassion and Acute Pain

Primary Purpose

Acute Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Self-Compassion
Acceptance
Distraction
Heat pain
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • sufficient german language knowledge
  • at least 18 years old

Exclusion Criteria:

  • acute or chronic pain conditions
  • drug or pain-medication (last 24 hours)
  • Raynaud's disease
  • high blood pressure
  • neuropathy, coronary diseases
  • diabetes, current alcohol
  • studying psychology longer than two years

Sites / Locations

  • Philipps-University of Marburg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Self-Compassion

Acceptance

Distraction

Arm Description

After pretreatment heat pain assessment, participants are introduced to the concept of self-compassion. Participants practice the new strategy with heat pain stimuli three times. Next, the posttreatment pain assessment is conducted. For a one week period, participants receive daily self-compassion audio-interventions. Afterwards, the follow-up pain assessment is conducted.

After pretreatment heat pain assessment, participants are introduced to the concept of acceptance. Participants practice the new strategy with heat pain stimuli three times. Next, the posttreatment pain assessment is conducted. For a one week period, participants receive daily acceptance audio-interventions. Afterwards, the follow-up pain assessment is conducted.

After pretreatment heat pain assessment, participants are introduced to the concept of distraction. Participants practice the new strategy with heat pain stimuli three times. Next, the posttreatment pain assessment is conducted. For a one week period, participants receive daily distraction audio-interventions. Afterwards, the follow-up pain assessment is conducted.

Outcomes

Primary Outcome Measures

Individual heat pain tolerance
Change in the individual heat pain tolerance (the point when participants cannot stand the heat pain stimulus any longer)

Secondary Outcome Measures

Pain intensity
Change in subjective pain intensity assessed using a numeric rating scale (ranging from 0 to 10, with higher values reflecting more pain intensity)
Change in pain unpleasantness scale
Change in subjective pain unpleasentness assessed using a numeric rating scale (ranging from 0 to 10, with higher values reflecting more pain unpleasentness)
Change in self-compassion
Change in overall self-compassion assessed using the self-compassion scale (Neff, 2003) (higher values indicating higher self-compassion

Full Information

First Posted
August 1, 2018
Last Updated
April 8, 2019
Sponsor
Philipps University Marburg Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03647683
Brief Title
Self-Compassion and Acute Pain
Official Title
Self-Compassion and Acute Pain - an Experimental Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philipps University Marburg Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Research on self-compassion suggests its impact in the context of pain. In the current study, the investigators evaluate a short self-compassion intervention for coping with acute pain.
Detailed Description
Self-compassion comprises three components: self-kindness, common humanity and mindfulness. Empirical evidence shows the relevance of self-compassion in the context of negative emotions such as depression, anxiety and anger. Research on chronic pain is promising yet limited. Self-compassion is associated with better pain-coping, pain-acceptance and quality of life, as well as reduced pain-related disability and burdening emotions. Experimental investigations on induced pain are missing. The aim of the current study is to evaluate a short self-compassion intervention for pain. First, a heat stimulus is induced to all participants which is to be tolerated as long as possible and evaluated in intensity and unpleasantness. Next, participants receive a coping-strategy which they are randomly assigned to. Three different strategies are evaluated: (1) self-compassion, treating oneself with kindness while being mindfully aware of the painful stimulus, (2) acceptance, accepting the painful stimulus as well as pain-related thoughts, not trying to change, (3) distraction, distracting oneself from the painful stimulus and trying not to perceive the pain or painful thoughts. Participants practice the strategy with the painful heat stimulus three times. Then, they receive another heat stimulus which is to be tolerated as long as possible and evaluated. During the next week, participants obtain daily practices via e-mail for further fostering of the learned strategy. Finally, participants receive, tolerate and evaluate pain again in the laboratory.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to one of three experimental groups in parallel for the duration of the study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-Compassion
Arm Type
Experimental
Arm Description
After pretreatment heat pain assessment, participants are introduced to the concept of self-compassion. Participants practice the new strategy with heat pain stimuli three times. Next, the posttreatment pain assessment is conducted. For a one week period, participants receive daily self-compassion audio-interventions. Afterwards, the follow-up pain assessment is conducted.
Arm Title
Acceptance
Arm Type
Experimental
Arm Description
After pretreatment heat pain assessment, participants are introduced to the concept of acceptance. Participants practice the new strategy with heat pain stimuli three times. Next, the posttreatment pain assessment is conducted. For a one week period, participants receive daily acceptance audio-interventions. Afterwards, the follow-up pain assessment is conducted.
Arm Title
Distraction
Arm Type
Experimental
Arm Description
After pretreatment heat pain assessment, participants are introduced to the concept of distraction. Participants practice the new strategy with heat pain stimuli three times. Next, the posttreatment pain assessment is conducted. For a one week period, participants receive daily distraction audio-interventions. Afterwards, the follow-up pain assessment is conducted.
Intervention Type
Other
Intervention Name(s)
Self-Compassion
Intervention Description
Participants are introduced to the concept of self-compassion. Treating oneself with kindness, while being mindfully aware of the present moment as well as the fact that suffering is part of human life - a shared human experience. Participants are instructed to use this strategy to cope with the following heat stimulus.
Intervention Type
Other
Intervention Name(s)
Acceptance
Intervention Description
Participants are introduced to the concept of acceptance. Thoughts, Emotions and Reactions do not need to be related. Being aware of the present moment helps with accepting the present state and reacting contradictory to the thoughts and feelings. Participants are instructed to use this strategy to cope with the following heat stimulus.
Intervention Type
Other
Intervention Name(s)
Distraction
Intervention Description
Participants are introduced to the concept of distraction. Distracting oneself from the present situation helps with not perceiving pain, painful thoughts or feelings. Participants are instructed to use this strategy to cope with the following heat stimulus.
Intervention Type
Other
Intervention Name(s)
Heat pain
Intervention Description
Participants receive heat pain stimuli using the Thermo Sensory Analyser (TSA-II), a commonly used device to study pain sensation and analgesic effects.
Primary Outcome Measure Information:
Title
Individual heat pain tolerance
Description
Change in the individual heat pain tolerance (the point when participants cannot stand the heat pain stimulus any longer)
Time Frame
Baseline, 45 min, 1 week
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Change in subjective pain intensity assessed using a numeric rating scale (ranging from 0 to 10, with higher values reflecting more pain intensity)
Time Frame
Baseline, 45 min, 1 week
Title
Change in pain unpleasantness scale
Description
Change in subjective pain unpleasentness assessed using a numeric rating scale (ranging from 0 to 10, with higher values reflecting more pain unpleasentness)
Time Frame
Baseline, 45 min, 1 week
Title
Change in self-compassion
Description
Change in overall self-compassion assessed using the self-compassion scale (Neff, 2003) (higher values indicating higher self-compassion
Time Frame
Baseline, 45 min, 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: sufficient german language knowledge at least 18 years old Exclusion Criteria: acute or chronic pain conditions drug or pain-medication (last 24 hours) Raynaud's disease high blood pressure neuropathy, coronary diseases diabetes, current alcohol studying psychology longer than two years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anja C Schmitt
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philipps-University of Marburg
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35032
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Self-Compassion and Acute Pain

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